Label: CHILDRENS ROBITUSSIN NIGHTTIME COUGH LONG-ACTING DM- chlorpheniramine maleate, dextromethorphan hydrobromide solution
- NDC Code(s): 0031-8692-13
- Packager: GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated June 10, 2022
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- Official Label (Printer Friendly)
- Active ingredients (in each 10 mL)
- INDICATIONS & USAGE
Do not use
- to sedate a child or to make a child sleepy
- if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
Ask a doctor before use if you have
- trouble urinating due to an enlarged prostate gland
- a cough that occurs with too much phlegm (mucus)
- a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis or emphysema
When using this product
- do not use more than directed
- marked drowsiness may occur
- avoid alcoholic drinks
- alcohol, sedatives, and tranquilizers may increase drowsiness
- be careful when driving a motor vehicle or operating machinery
- excitability may occur, especially in children
Stop use and ask a doctor if cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.
DOSAGE & ADMINISTRATION
- measure only with dosing cup provided
- keep dosing cup with product
- mL = milliliter
- do not take more than 4 doses in any 24-hour period
Children under 6 years
do not use
children 6 to under 12 years
10 mL every 6 hours
adults and children 12 years and older
20 mL every 6 hours
- STORAGE AND HANDLING
- INACTIVE INGREDIENT
Packaged with Tamper-Evident bottle cap. Do Not Use if breakable ring is separated or missing.
Children’s Robitussin liquid is specially formulated to provide soothing action, control your child’s cough plus relieve other cold symptoms.
Should be 18 or older to purchase
Learn about teen medicine abuse
Use dosage cup included
Distributed by: GSK Consumer Healthcare,
Warren, NJ 07059
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©2022 GSK or licensor
Made in Canada
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INGREDIENTS AND APPEARANCE
CHILDRENS ROBITUSSIN NIGHTTIME COUGH LONG-ACTING DM
chlorpheniramine maleate, dextromethorphan hydrobromide solution
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0031-8692 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE 2 mg in 10 mL DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 15 mg in 10 mL Inactive Ingredients Ingredient Name Strength ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) FD&C RED NO. 40 (UNII: WZB9127XOA) GLYCERIN (UNII: PDC6A3C0OX) LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SODIUM BENZOATE (UNII: OJ245FE5EU) SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR) SORBITOL (UNII: 506T60A25R) SUCRALOSE (UNII: 96K6UQ3ZD4) Product Characteristics Color RED (red) Score Shape Size Flavor FRUIT PUNCH Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0031-8692-13 1 in 1 CARTON 07/01/2014 1 118 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 07/01/2014 Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)